Brief Title
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
Brief Summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical
precancerous lesions in adult women.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Secondary Outcome
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Condition
HSIL
Intervention
ABI-1968
Study Arms / Comparison Groups
Dose 1 - Multiple Ascending Dose (MAD)
Description: ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
January 1, 2018
Completion Date
October 30, 2018
Primary Completion Date
October 30, 2018
Eligibility Criteria
Inclusion Criteria:
- Women, 25 to 50 years old.
- Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy
with no evidence of invasive cancer in any specimen and must be p16+.
- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose
and 2 days after each dose.
- Generally experiencing regular menstrual cycles, unless using long-acting reversible
contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
Exclusion Criteria:
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating
females.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal
infection.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of
CIN, or hysterectomy.
Gender
Female
Ages
25 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03239223
Organization ID
ABI-1968-102
Responsible Party
Sponsor
Study Sponsor
Antiva Biosciences
Study Sponsor
, ,
Verification Date
July 2019